T:slim Insulin Delivery System Insulin Infusion Pump — Class I medical device recall Z-0827-2014
Terminated recall by Tandem Diabetes Care Inc, reported 2014-02-19, distributed nationwide. Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A c
| Recall number | Z-0827-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tandem Diabetes Care Inc, San Diego, CA, United States |
| Recall initiated | 2014-01-10 |
| Classified | 2014-02-10 |
| Reported by FDA | 2014-02-19 |
| Terminated | 2014-09-23 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | M000857, M000869, M001344, M001345, M001346, M001347, M001389, M001390, M001391, M001392, M001393, M001414, M001415, M001416, M001417, M001420, M001421, M001422, M001423, M001451, M001452, M001453, M001454, M001455, M001456, M001457, M001458, M001459, M001460, M001528, M001529, M001530, M001532, M001963, M001964, M001973, M001974, M001979, M001980, M001987 and 15 more |
Product
T:slim Insulin Delivery System Insulin Infusion Pump
Reason for recall
Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which can lead to a serious adverse event.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0827-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.